Cleared Special

BD ChloraShield IV Dressing with CHG Antimicrobial (K152923) - FDA 510(k) Clearance

K152923 · Avery Dennison Belgie Bvba · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
31d
Days
-
Risk

K152923 is an FDA 510(k) clearance for the BD ChloraShield IV Dressing with CHG Antimicrobial. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on November 5, 2015 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Avery Dennison Belgie Bvba devices

Submission Details

510(k) Number K152923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2015
Decision Date November 05, 2015
Days to Decision 31 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
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